Clinical research and the role of the Research Nurse

Transcription

1 Clinical research and the role of the Research Nurse Anele Waters Senior Research Charge Nurse Grahame Hayton Unit Barts Health Trust-The Royal London Research definitions History of guidelines and regulations Role of the Research Team Role of the Research Nurse Organisation and Funding of UK Research

2 What is Clinical Research? Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.. National Institute for Health,USA (NIH) What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. National Institute for Health,USA (NIH)

3 Terminology Controlled trial: comparing groups to a standard Blinding: concealment of the group assignment Randomisation: participants are assigned to arms of a clinical trial by chance Randomised Control Trial (RTC): Gold standard for clinical trials Phases of Clinical Trials Phase I: 1 st in man, safety, pharmacokinetics o Healthy volunteers, 10 s - days Phase II: safety, efficacy ohiv +ve, 100 s - months Phase III: safety, efficacy, side effects ohiv +ve 100 s-1000 s - years Phase IV: post-marketing surveillance studies

4 Development of Clinical Trials Regulations Nazi Experiments Nuremburg trials

5 1. Voluntary consent Nuremburg Code 2. Beneficial to society, results not found by other means 3. Knowledge base prior to study 4. Cause no physical or mental suffering 5. Cause no death or disability 6. Benefit should outweigh risk 7. Proper preparation & facilities 8. Qualified scientific persons 9. Subject can withdraw at any time 10. Study can be terminated at any time to prevent death or injury Thalidomide

6 Guidance and Law 1964: Declaration of Helsinki 1965: European Community Pharmaceutical Directive (65/65/EEC) 1996: International Conference on Harmonization-ICH-6:Good Clinical Practice (GCP) Clinical Trials Directive (2001/20/EC) GCP Directive (2005/28/EC) The Medicines for Human Use (Clinical Trials) Regulations of 2004 (SI 2004/1031) 13 March 2006 Phase 1 trial/tgn1412 monoclonal antibody 6 Volunteers hospitalised

7 The Research Team Principal Investigator Research Nurse Study Sponsor The Study Participant CRO/Study Monitor Co-investigators Data entry assistant Study Pharmacist

8 The Clinical Research Nurse What is a Clinical Research Nurse A nurse who is employed principally to undertake research within the clinical environment. Bands 5-8 Variety of funding streams (NHS,Pharma,CLRN) Gibbs CL, Lowton K (2012) The role of the clinical research nurse. Nursing Standard. 26, 27, Date of acceptance: December

9 Knowledge and Responsibilities Clinical Managerial Educational Clinical Primary advocate for the patient Communication with study patient Knowledge about disease under study Monitoring participants-vital signs, lab tests Tissue and sample collection and processing Informed consent Drug administration Adverse event management

10 Managerial Management and co-ordination of research studies Submission and maintenance of ethics and regulatory documents Screening and Recruitment of patients into studies Maintenance of study files resolving data queries Data Collection, documentation and reporting Preparation of samples for storage and shipment Financial account management

11 Educational Ensuring study team member is familiar with protocol, amendments and their role within the team Training and supervising nursing, medical and new research team members. Your role (To know) Be aware of research ongoing in your area Understand the importance of documentation Report adverse events or serious adverse events to the research team

12 Funding and Organisation of Research in the UK National Institute for Health Research (NIHR) Created in April 2006 Provides structure and funding Clinical Research Networks established 2006 UK Clinical Research Network Portfolio Created Research Passport scheme in 2007 Coordinated System for Gaining NHS permissions in 2008

13 NHS commitment to Research NHS pledge (Section 3a NHS Constitution 2013) The NHS commits to inform you of research studies in which you may be eligible to participate. This pledge aims to give people better access to the potential benefits of participating in research studies including clinical trials f role of research in the NHS Government Commitment to Health Research These papers confirm research as a core role of the NHS The Coalition Programme 2010 The NHS White Paper, 2010 The NIHR Annual Report, 2010 The Public Health White Paper, 2010 The Spending Review, 2010 The Arm s-length Bodies Review, 2010 The Command Paper, 2010 The PM speech on life sciences and opening up the NHS, 2011 The UK Life Science Strategy, 2011 The Plan for Growth, 2011 The NHS Outcomes Framework, 2011/12; 2012/13; 2013/14 The NHS Operating Framework, 2011/12; 2012/13 The Health and Social Care Act, 2012 The NHS Constitution, March /file/170656/nhs_constitution.pdf role of research in the NHS

14 Summary Extensive guidelines and regulations have developed as a result of experience Research nurses work to a high standard of regulation Guidelines and regulations are in place primarily for the safety of the research participants Research nurses play a pivotal role in the clinical environment All nurses have a role to play within research

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